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news.Watson Pharmaceuticals has announced that the FDA has accepted for filing its new drug application for oxybutynin chloride topical gel.
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Watson is seeking marketing approval of this novel transdermal gel of oxybutynin hydrochloride for the treatment of overactive bladder (OAB). Oxybutynin chloride topical gel (OTG) is a clear, rapid-drying gel designed to produce consistent oxybutynin concentrations over a 24-hour period. By administering oxybutynin through the skin, OTG avoids first pass metabolism and the resultant high metabolite levels seen with oral oxybutynin dosing.
The NDA filing for OTG is based on data from a Phase III randomized, double-blind, placebo-controlled study involving 789 patients with OAB. In the 12-week study, patients treated with OTG once daily experienced a highly significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day, a decrease in urinary frequency and an increase in the average urine volume per void.
Ed Heimers, Jr, executive vice president and president of Watson’s Brand Division, said: “We believe this new formulation of oxybutynin signifies an important advancement in treatment options for OAB as it offers the benefits of transdermal therapy with excellent skin tolerability.”